sE PUBLIS IN THE EXTRA IARY GAZI F PAKISTAN, Government of Pakistan Ministry of National Health Services, Regulations & Coordination Drug Regulatory Authority of Pakistan T.F. Complex, Sector G-9/4, Islamabad Islamabad, the 02" July, 2020 NOTIFICATION F.No.4-2/2017- DD(H&OTC),- In exercise of the powers conferred by the Section 7 (c)(x), (i) and (q) of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), read with definitions (xIvii (alix ) and (1) of sub rule (1) of rule 2 of SRO.412(1y2014_ dated 27" May, 2014, further read with the condition “e” of Provisional Certificate for Enlistment as a Manufacture/Importer (Form-6) and the condition “o” of Provisional Certificate for Enlistment of Product (Form-7) of the aforesaid rules, the Drug Regulatory Authority of Pakistan is pleased to issue the following guidelines for products enlisted under the provisions of aforesaid rules, namely:~ 1) The follo the enlisted Alternative Medicines & Health Products; “box information / labelling requirements” are hereby made mandatory for all (@) the top of the label of altemative medicines shall conspicuously bear the words in prominent bold ink, in English and Urdu language for respective category / system of treatment, as the case may be, as under:~ English “Alternative Medicine — Herbal / Unani / Ayurvedic / Homoeopathic / Biochemic, Chinese”, Urd Cy ILE) Gio sete | Sgt 1 Sty 1 Bn) b> (b) the top of the label of Food Supplements / Nutraceuticals / Nutritional Supplements shall conspicuously bear the words in prominent bold ink in English and Urdu language, as the case may be, as under:~ English : “Food Supplements / Nutraceuticals / Nutritional Supplements — Not for treatment of any disease” Urd FE WL Sg SON eR I Barta eed 2) The above labelling instructions are applicable with immediate effect, on those products whose product enlistment certificates are issued after the date of this notification. However, the products whose product enlistment certificates have been issued prior to the issuance of this notification, shall be relaxed from above labelling instructions till the expiry of the products whose batches have been manufactured before the issuance of this notification. ky ‘GHAFFAR) ™ ADDFTTONAL DIRECTOR/SECRETARY EEC The Manager, Printing Corporation of Pakistan, Islamabad.